department testing laboratory medical iso 15189

52
115 Accreditation No. ISO 15189 Testing Laboratory-Medical Department: 115-04 Appendix to Certificate No. Date of issue 26.08.2013 Version No. 4 Page No. 1 of: 52 התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספחThe certificate attached is an integral part of the schedule and is numbered identically Name and Address: The Chaim Sheba Medical Center Tel Hashomer 52621 Israel Organization name Address +972-3-530-3078 Phone +972-3-530-3991 Fax [email protected] E-Mail (contact person) This appendix includes 9 parts, one for each accredited organization in the list below: 1. Automated Mega laboratory Phone No. +972-3-530-2253 2. AIDS Phone No. +972-3-530-3401 3. Blood Bank Phone No. +972-3-530-2570 4. Coagulation Laboratory Phone No. +972-3-530-2105 5. Endocrinology Laboratory Phone No. +972-3-530-2022 +972-3-530-3082 6. Gastroenterology Laboratory Phone No. +972-3-530-2905 7. Hematology Laboratory Phone No. +972-3-530-2356 8. Lipids and Atherosclerosis Laboratory Phone No. +972-3-530-2940 9. Clinical Toxicology & Pharmacology Phone No. +972-3-530-2358

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Page 1: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Date of issue 26.08.2013 Version No. 4 Page No. 1 of: 52 The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

The Chaim Sheba Medical Center

Tel Hashomer 52621 Israel

Organization name

Address

+972-3-530-3078 Phone

+972-3-530-3991 Fax

[email protected] E-Mail (contact person)

This appendix includes 9 parts, one for each accredited organization in the list below:

1. Automated Mega laboratory Phone No. +972-3-530-2253

2. AIDS Phone No. +972-3-530-3401

3. Blood Bank Phone No. +972-3-530-2570

4. Coagulation Laboratory Phone No. +972-3-530-2105

5. Endocrinology Laboratory Phone No. +972-3-530-2022 +972-3-530-3082

6. Gastroenterology Laboratory Phone No. +972-3-530-2905

7. Hematology Laboratory Phone No. +972-3-530-2356

8. Lipids and Atherosclerosis Laboratory Phone No. +972-3-530-2940

9. Clinical Toxicology & Pharmacology Phone No. +972-3-530-2358

Page 2: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 2 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

Automated Megalaboratory

Tel Hashomer 52621

Israel

Organization name

Laboratory name

Address

+972-3-530-2253, +972-3-530-2100 Phone +972-3-530-3498 Fax [email protected]

[email protected]

E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

Opinion and Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

1 A P Albumin אלבומין Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

2 A P Alkaline Phosphatase Alkaline Phosphatase Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

3 A P Amylase עמילאז Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

4 A P Bilirubin (Total) )בילירובין )כללי Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

Page 3: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 3 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

5 A P CA 125 CA 125 Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunometric-

Chemiluminescence kit by

Beckman Coulter

DxI 800

---

6 A P CA 15.3 CA 15.3 Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunometric-

Chemiluminescence kit by Beckman Coulter

DxI 800 ---

7 A P CA 19.9 CA 19.9 Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunometric-

Chemiluminescence kit by

Beckman Coulter

DxI 800

---

8 A P Calcium סידן Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5811 ---

9 A P CEA CEA Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunometric-

Chemiluminescence kit by Beckman Coulter

DxI 800 ---

10 A P Chloride כלוריד Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Indirect ISE (Ion Selective

Electrode)

AU5800 ---

11 A P Cholesterol כולסטרול Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

12 A P C-Reactive Protein C-Reactive Protein Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Immuno-Turbidimetric

high sensitivity

kit by Beckman Coulter

AU5800 ---

13 A P Creatine Kinase (CK) Creatine Kinase (CK) Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5811 ---

14 A P Creatine Kinase -MB

Iisoenzyme (CK-MB)

Creatine Kinase -MB

Iisoenzyme (CK-MB)

Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

Page 4: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 4 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

15 A P Creatinine Creatinine Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

16 A P Digoxin Digoxin Serum סרום Immunoassay/

Chemiluminescence kit by

Beckman Coulter

DxI 800

---

17 A P Ferritin Ferritin Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunometric-

Chemiluminescence kit by Beckman Coulter

DxI 800 ---

18 A P Folic acid חומצה פולית Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunometric-

Chemiluminescence kit by

Beckman Coulter

DxI 800

---

19 A P GGT (Gama(γ)-

glutamyl

transpeptidase)

GGT (Gama(γ)-glutamyl

transpeptidase)

Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

20 A P Glucose גלוקוז Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

21 A P Iron ברזל Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

22 A P LDH (Lactate

Dehydrogenase)

LDH (Lactate

Dehydrogenase) Serum/Plasma

(LiHeparine) פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

23 A P Lipase ליפאז Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

24 A P Magnesium מגנזיום Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

Page 5: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 5 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

25 A P Phosphorus Phosphorus Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

26 A P Potassium אשלגן Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Indirect ISE (Ion Selective

Electrode)

AU5800 ---

27 A P Protein (Total) )חלבון )כלל Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

28 A P SGOT (Serum

Glutamic Oxaloacetic

Transaminase)

AST (Aspartate aminotransferase)

SGOT (Serum Glutamic

Oxaloacetic

Transaminase)

AST (Aspartate aminotransferase)

Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800

---

29 A P SGPT (Serum

Glutamic Pyruvic

Transaminase) ALT (Alanine

aminotransferase)

SGPT (Serum Glutamic

Pyruvic Transaminase)

ALT (Alanine aminotransferase)

Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800

---

30 A P Sodium נתרן Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Indirect ISE (Ion Selective

Electrode)

AU5800 ---

31 A P Troponin I (aTnI) Troponin I (aTnI) Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunoassay/

Chemiluminescence kit by Beckman Coulter

AccuTnI, Optimized

DxI 800

---

32 A P Urea Urea Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800

---

Page 6: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 6 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

Chemical Testing, Autoanalysers בדיקות כימיות, שיטות באוטואנלייזרים

33 A P Uric Acid Uric Acid Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Colorimetric-endpoint

kit by Beckman Coulter

AU5800 ---

34 A P Vitamin B12

(Cyanocobalamin)

Vitamin B12

(Cyanocobalamin)

Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunometric-

Chemiluminescence kit by

Beckman Coulter

DxI 800 ---

Page 7: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 7 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים

Biological Testing, Immunoassays by Autoanalysers אימונוכימיות באוטואנלייזרים שיטות, בדיקות ביולוגיות

35 A P AFP (Alpha

Fetoprotein)

AFP (Alpha Fetoprotein) Serum סרום Immunometric-

Chemiluminescence kit by

Beckman Coulter

DxI 800 ---

36 A P Free T4 (FT4)

(Thyroxine, Free)

Free T4 (FT4)

(Thyroxine, Free)

Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunocompetitive-

Chemiluminescence kit by

Beckman Coulter

DxI 800 ---

37 A P FT3 (FreeT3)

(triiodothyronine,

Free)

FT3 (FreeT3)

(triiodothyronine, Free)

Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunocompetitive-

Chemiluminescence kit by

Beckman Coulter

DxI 800 ---

38 A P PSA-free (Prostate

Specific Antigen-free)

PSA-free (Prostate

Specific Antigen-free)

Serum סרום Immunometric-

Chemiluminescence kit by

Beckman Coulter

Hybritech

DxI 800

---

39 A P PSA-total (Prostate

Specific Antigen -total)

PSA-total (Prostate

Specific Antigen -total)

Serum סרום Immunometric-

Chemiluminescence kit by Beckman Coulter

Hybritech

DxI 800

---

40 A P TSH (Thyroid

Stimulating Hormone)

TSH (Thyroid

Stimulating Hormone)

Serum/Plasma

(LiHeparine)

פלסמה סרום/

(LiHeparine) Immunometric-

Chemiluminescence kit by Beckman Coulter

Hypersensitive

DxI 800

---

Page 8: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 8 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry,

Hemodynamics and Oxymetry

כימיה, ביוכימיה כללית, המודינמיקה ואוקסימטריה -בריאות, רפואה משפחת מוצרים:

Chemical Testing, Autoanalysers באוטואנלייזרים שיטות, בדיקות כימיות

41 A P (K) Potassium אשלגן Whole blood (Na

Heparin) Direct ISE (Ion Selective (Na Heparin)דם מלא

Electrode)

Cobas b 221 ---

42 A P (Na ) Sodium נתרן Whole blood (Na

Heparin), Plasma / (Na Heparin)דם מלא

פלסמהDirect ISE (Ion Selective

Electrode) Cobas b 221

---

43 A P (PCO2) Carbon

dioxide, Partial

Pressure

(PCO2) Carbon dioxide,

Partial Pressure

Whole blood (Na

Heparin) Direct ISE (Ion Selective (Na Heparin)דם מלא

Electrode)

Cobas b 221

---

44 A P (PO2) Oxygen, Partial

Pressure

(PO2) Oxygen, Partial

Pressure

Whole blood (Na

Heparin) Amperometry Cobas b 221 (Na Heparin)דם מלא

---

45 A P (SO2%) Oxygen

Saturation,

(SO2%) Oxygen

Saturation,

Whole blood (Na

Heparin) Light absorption in whole (Na Heparin)דם מלא

blood

Cobas b 221 ---

46 A P BE (Base excess) BE (Base excess) Whole blood (Na

Heparin) Calculated Cobas b 221 (Na Heparin)דם מלא

--- Calculated

47 A P Ca2+(Ionized calcium) Ca2+(Ionized calcium) Whole blood (Na

Heparin) Direct ISE (Ion Selective (Na Heparin)דם מלא

Electrode)

Cobas b 221 ---

48 A P CO.Hb

(Carboxyhemoglobin)

CO.Hb

(Carboxyhemoglobin)

Whole blood (Na

Heparin) (Na Heparin)מלא דם

Spectrophotometry Cobas b 221

---

49 A P Glucose גלוקוז Whole blood (Na

Heparin) Amperometry (Na Heparin)דם מלא

Cobas b 221 ---

50 A P HCO3 (Bicarbonate) HCO3 (Bicarbonate) Whole blood (Na

Heparin) Calculated Cobas b 221 (Na Heparin)דם מלא

--- Calculated

51 A P Lactate, (Lactic Acid) חומצה לקטית Whole blood דם מלא Amperometry Cobas b 221 ---

Page 9: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 9 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry,

Hemodynamics and Oxymetry

ית, המודינמיקה ואוקסימטריהכימיה, ביוכימיה כלל -בריאות, רפואה משפחת מוצרים:

Chemical Testing, Autoanalysers ,באוטואנלייזרים שיטותבדיקות כימיות

52 A P Met.Hb (Met-

hemoglobin)

Met.Hb (Met-

hemoglobin)

Whole blood (Na

Heparin) (Na Heparin)דם מלא

Spectrophotometry Cobas b 221

---

53 A P pH pH Whole blood (Na

Heparin) Hydrogen ion selective glass (Na Heparin)דם מלא

Electrode

Cobas b 221 ---

Page 10: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 10 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Blood Count :המטולוגיה, ספירה -בריאות, רפואה משפחת מוצרים

Biological Testing, Blood Count by Autoanalysers באוטואנלייזרים ספירה, יותבדיקות ביולוג

54 A P CBC (Complete Blood

Count)

Whole blood ספירת דם כללית

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

--- Including all parameter listed

below

55 A P Basophils Basophils Whole blood

(KEDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

56 A P Blasts Blasts Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

57 A P Eosinophils Eosinophils Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

58 A P Hematocrit Hematocrit Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

59 A P Hemoglobin המוגלובין Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

60 A P Hypercytosis Hypercytosis Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

61 A P Hypocytosis Hypocytosis Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

62 A P Left shift Left shift Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

63 A P Lymphocytes Lymphocytes Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

64 A P Macrocytes Macrocytes Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

65 A P MCH (Mean Cell

Hemoglobin)

MCH (Mean Cell

Hemoglobin)

Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

Page 11: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 11 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Blood Count :המטולוגיה, ספירה -בריאות, רפואה משפחת מוצרים

Biological Testing, Blood Count by Autoanalysers ,באוטואנלייזרים ספירהבדיקות ביולוגיות

66 A P MCHC (Mean Cell

Hemoglobin

Concentration)

MCHC (Mean Cell

Hemoglobin

Concentration)

Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

67 A P MCV (Mean Cell

Volume)

MCV (Mean Cell

Volume)

Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

68 A P Microcytes Microcytes Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

69 A P Monocytes Monocytes Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

70 A P MPV (Mean Platelet

Volume)

MPV (Mean Platelet

Volume)

Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

71 A P Neutrophils

(Polymorphonuclears)

Neutrophils

(Polymorphonuclears)

Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

72 A P PCT (Platelets

Hematocrit)

PCT (Platelets

Hematocrit)

Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

73 A P PLT (Platelets) PLT (Platelets) Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

74 A P RBC (Red Blood

Cells)

Whole blood תאי דם אדומים

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

75 A P RDW (Red Blood Cell

Distribution Width)

RDW (Red Blood Cell

Distribution Width)

Whole blood

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

76 A P WBC (White Blood

Cells)

Whole blood תאי דם לבנים

(K2EDTA) EDTA)2(K Automated cell counter LH 750דם מלא

---

Page 12: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 12 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology המטולוגיה -בריאות, רפואה מוצרים: משפחת

Biological Testing, Blood Cell Typing Manual smear ידני משטח ,בדיקות ביולוגיות, אפיון תאי דם

77 A P Blood Smears or

Films:

Normal blood films

Young cells: Stabs,

MetaMyelocytes,

Myelocytes,

Promyrlocytes, Blasts.

Atypical Lymphocytes.,

Monocytes,

Granulocytes Red Blood Cell

pathology.

Leukemic blood smears.

Abnormalities in

Platelets.

Blood Smears or Films:

Normal blood films

Young cells: Stabs,

MetaMyelocytes,

Myelocytes,

Promyrlocytes, Blasts.

Atypical Lymphocytes.,

Monocytes, Granulocytes

Red Blood Cell

pathology. Leukemic blood smears.

Abnormalities in

Platelets.

Whole blood דם מלא Microscopy on Gimsa stained

slides.

Manual and

automatically spread

blood smears by

Beckman Coulter LH 755.

---

Page 13: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 13 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Coagulation :המטולוגיה, קרישה -בריאות, רפואה משפחת מוצרים

Biological Testing, Autoanalysers וטואנלייזריםבא שיטות, בדיקות ביולוגיות

78 A P D-Dimer D-Dimer Plasma (Na Citrate)

(Na Citrate)פלסמה Immunoturbidimetric kit by IL ACL Top ---

79 A P Fibrinogen

פיברינוגן

Plasma (Na Citrate) Clot detection (Na Citrate)פלסמה

Photometry kit by IL

ACL Top ---

80 A P INR (International

Normalizing Ratio)

INR (International

Normalizing Ratio)

Plasma (Na Citrate) פלסמה(Na Citrate) Calculation ACL Top ---

81 A P PT (ProthrombinTime) PT (ProthrombinTime) Plasma (Na Citrate) פלסמה(Na Citrate) Clot detection

Photometry

kit by IL

ACL Top

---

82 A P PTT (Partial Thromboplastin Time)

PTT (Partial Thromboplastin Time)

Plasma (Na Citrate) פלסמה(Na Citrate) Clot detection

Photometry

kit by IL

ACL Top ---

83 A P TT (Thrombin Time) TT (Thrombin Time) Plasma (Na Citrate) פלסמה(Na Citrate) Clot detection

Photometry

kit by IL

ACL top ---

Page 14: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 14 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Microbiology, Viruses :מיקרוביולוגיה, נגיפים -בריאות, רפואה משפחת מוצרים

Biological Testing, Non Culture Identification Ttyping - Immunoassays in

Autoanalysers

באוטואנלייזרים אימונוכימיות שיטות – תרבית ללא ואפיון זיהויבדיקות ביולוגיות,

84 A P Virus: HCV (Hepatitis

C Virus) Ab

Virus: HCV (Hepatitis C

Virus) Ab

Serum סרום CMIA ARCHITECT Abbott

Kit ---

CMIA= Chemiluminescent

Microparticle Immuno Assay

85 A P Virus: Hepatitis. B

Surface Ag

Virus: Hepatitis. B

Surface Ag

Serum סרום CMIA ARCHITECT Abbott

Kit ---

Page 15: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 15 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

AIDS

Tel Hashomer 52621

Israel

Organization name

Laboratory name

Address

+972-3-530-3401 Phone +972-3-530-3501 Fax [email protected] E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Microbiology, Viruses :מיקרוביולוגיה, נגיפים -בריאות, רפואה משפחת מוצרים

Biological Testing, Non Culture Identification Ttyping - Immunoassays in

Autoanalysers

באוטואנלייזרים אימונוכימיות שיטות – תרבית ללא ואפיון זיהוי בדיקות ביולוגיות,

86 A P HIV Ab/Ag HIV Ab/Ag Serum/Plasma סרום / פלסמה CMIA ARCHITECT

---

CMIA= Chemiluminescent

Microparticle Immuno Assay

Kit-HIV Ag/Ab Combo

Page 16: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 16 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

Blood Bank

Tel Hashomer 52621 Israel

Organization name

Laboratory name

Address

+972-3-530-2570 Phone

+972-3-530-5294 Fax

[email protected] E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Blood Bank :בנק דם -בריאות, רפואה משפחת מוצרים

Biological Testing, Immunoassays by Autoanalysers / manual ידניות/באוטואנלייזרים אימונוכימיות שיטות, בדיקות ביולוגיות

87 A P Antibody screening Antibody screening Whole blood דם מלא Agglutination Tube ---

88 A P Antibody screening Antibody screening Whole blood דם מלא Agglutination DiaMed Gel ---

89 A P Antibody screening Antibody screening Whole blood דם מלא Agglutination Auto-Vue System ---

Automatic System

90 A P Antibody screening Antibody screening Whole blood דם מלא Agglutination iH-1000 System ---

Automatic System

91 A P Blood type: A, B, O,

AB, Rh / Weak D

Blood type: A, B, O,

AB, Rh / Weak D

Whole blood דם מלא Agglutination Tube using Gamma

reagents ---

92 A P Blood type: A, B, O,

AB, Rh / Weak D

Blood type: A, B, O,

AB, Rh / Weak D

Whole blood

Agglutination DiaMed Gel דם מלא---

Page 17: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 17 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Blood Bank :בנק דם -בריאות, רפואה משפחת מוצרים

Biological Testing, Immunoassays by Autoanalysers / manual ידניות/באוטואנלייזרים אימונוכימיות שיטות, יולוגיותבדיקות ב

93 A P Blood type: A, B, O,

AB, Rh / Weak D

Blood type: A, B, O,

AB, Rh / Weak D

Whole blood דם מלא Agglutination Auto-Vue System ---

Automatic System

94 A P Blood type: A, B, O,

AB, Rh / Weak D

Blood type: A, B, O,

AB, Rh / Weak D

Whole blood דם מלא Agglutination iH-1000 System ---

Automatic System

95 A P Compatibility התאמה Whole blood דם מלא IAT Tube ---

IAT=Indirect Anti globulin

Test

96 A P Compatibility התאמה Whole blood לאדם מ IAT DiaMed Gel ---

97 A P Compatibility התאמה Whole blood דם מלא IS Tube ---

IS= Immediate Spin

98 A P Serologic confirmation

of ABO/Rh Serologic confirmation

of ABO/Rh Whole blood דם מלא Agglutination Tube

---

Page 18: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 18 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

Coagulation Laboratory

Tel Hashomer 52621 Israel

Organization name

Laboratory name

Address

+972-3-530-2105 Phone +972-3-535-1568 Fax [email protected] E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

Opinion and Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Coagulation :המטולוגיה, קרישה -בריאות, רפואה משפחת מוצרים

Biological Testing, Autoanalysers ,באוטואנלייזרים שיטות בדיקות ביולוגיות

99 A P Antithrombin Antithrombin Plasma,

(Na Citrate) Na Citrate)) Chromogenicפלסמה

Kit Liquid ATIII: IL

ACL Top 500 ---

100 A P APCR (Activated

Protein C Resistance)

APCR (Activated

Protein C Resistance)

Plasma,

(Na Citrate) Na Citrate)) Clot detection photometryפלסמה

Kit FV Leiden APCR V: IL

ACL Top 500 ---

101 A P CAC (Circulating Anti

Coagulant)

CAC (Circulating Anti

Coagulant)

Plasma,

(Na Citrate)

Na Citrate)) Clot detection photometryפלסמה

PTT NS- Actin FS: Siemens

PTT LA S: Stago dRVVT Screen: IL

dRVVT Confirm : IL

ACL Top 500

---

102 A P Factor II Factor II Plasma, (Na Citrate)

Na Citrate)) Clot detection photometryפלסמה Factor II DP:IL

PT Recomboplastin: IL

ACL Top 500

---

DP- Deficient plasma

Page 19: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 19 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Coagulation :המטולוגיה, קרישה -בריאות, רפואה משפחת מוצרים

Biological Testing, Autoanalysers ,שיטות באוטואנלייזרים בדיקות ביולוגיות

103 A P Factor IX Factor IX Plasma,

(Na Citrate) Na Citrate)) Clot detection photometryפלסמה

Factor IX DP: IL

PTT Synthasil IL

ACL Top 500

---

104 A P Factor V Factor V Plasma,

)Na Citrate) Na Citrate)) Clot detection photometryפלסמה

Factor V DP:IL

PT Recomboplastin: IL

ACL Top 500

---

105 A P Factor VII Factor VII Plasma,

(Na Citrate) Na Citrate)) Clot detection photometryפלסמה

Factor VII DP:IL PT Recomboplastin: IL

ACL Top 500 ---

106 A P Factor VIII Factor VIII Plasma,

(Na Citrate) Na Citrate)) Clot detection photometryפלסמה

Factor VIII DP: IL

PTT Synthasil IL

ACL Top 500

---

107 A P Factor X Factor X Plasma,

(Na Citrate) Na Citrate)) Clot detection photometryפלסמה

Factor X DP:IL

PT Recomboplastin: IL

ACL Top 500

---

108 A P Factor XI Factor XI Plasma,

(Na Citrate)

Na Citrate)) Clot detection photometryפלסמה

Factor XI DP: IL

PTT Synthasil IL

ACL Top 500

---

109 A P Factor XII Factor XII Plasma,

(Na Citrate)

Na Citrate)) Clot detection photometryה פלסמ

Factor XII DP: IL

PTT Synthasil IL

ACL Top 500

---

110 A P Free Protein S antigen Free Protein S antigen Plasma,

(Na Citrate)

Na Citrate)) Immun-agglutinationפלסמה

Kit free Protein S: IL

ACL Top 500

---

Page 20: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 20 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Coagulation :המטולוגיה, קרישה -בריאות, רפואה משפחת מוצרים

Biological Testing, Autoanalysers ,שיטות באוטואנלייזרים בדיקות ביולוגיות

111 A P Inhibitor to clotting

factor

Inhibitor to clotting

factor

Plasma,

(Na Citrate)

Na Citrate)) Clot detection photometryפלסמה

See specific factors

ACL Top 500

---

112 A P INR Recomboplastin

2G (International Normalized Ratio)

INR Recomboplastin

2G (International Normalized Ratio)

Plasma,

(Na Citrate) Na Citrate)) Calculation ACL Top 500פלסמה

---

113 A P Protein C Protein C Plasma,

(Na Citrate)

Na Citrate)) Chromogenicפלסמה

Kit Coamatic Protein C:

Chromogenix

ACL Top 500

---

114 A P PT Recomboplastin

2G (Prothrombin Time %)

PT Recomboplastin 2G

(Prothrombin Time %)

Plasma,

)Na Citrate) Na Citrate)) Clot detection photometryפלסמה

Reagent: IL

ACL Top 500 ---

115 A P PTT Synthasil (Partial

Thromboplastin Time)

PTT Synthasil (Partial

Thromboplastin Time)

Plasma,

)Na Citrate) Na Citrate)) Clot detection photometryפלסמה

Reagent: IL

ACL Top 500 ---

116 A P VWF (Von

Willebrand Factor)

antigen

VWF (Von Willebrand

Factor) antigen

Plasma,

(Na Citrate) Na Citrate)) Immun-agglutination VWFפלסמה

Antigen: IL

ACL Top 500

---

Page 21: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 21 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Coagulation :המטולוגיה, קרישה -בריאות, רפואה משפחת מוצרים

Biological Testing, Immunoassays שיטות אימונוכימיות, בדיקות ביולוגיות

117 A P Factor XIII Factor XIII Plasma,

(Na Citrate) Na Citrate)) Enzymatic Kitפלסמה

Berichrom FXIII: Siemens

Elisa reader ---

118 A P Diagnosis of Hit-

Heparin Induced Thrombocytopenia

Serum סרום Immunoagglutination by

PaGIA kut from Biorad

ID Card centrifuge,

Diamed ---

Page 22: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 22 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Coagulation :המטולוגיה, קרישה -בריאות, רפואה משפחת מוצרים

Biological Testing, Molecular Methods מולקולאריות בשיטות, בדיקות ביולוגיות

119 A P Factor V Leiden Factor V Leiden Whole blood (DNA) דם מלא(DNA) SNP Detection by

TaqMan with specific

fluorescent probes

RT PCR ABI 7500 Applied Biosystem

---

RT-PCR= Real time

Polymerase Chain Reaction

SNP- Single Nucleotide

polymorphism

120 A P MTHFR C677T

(Methylenetetrahydrofolate reductase)

MTHFR C677T

(Methylenetetrahydrofolate reductase)

Whole blood (DNA) דם מלא(DNA) SNP Detection

by TaqMan with specific fluorescent probes

RT PCR ABI 7500

Applied Biosystem ---

121 A P Protrombin G20210A Protrombin G20210A Whole blood (DNA) דם מלא(DNA) SNP Detection

by TaqMan with specific

fluorescent probes

RT PCR ABI 7500

Applied Biosystem ---

122 A P HPA 1,2,3,5,9,15 HPA 1,2,3,5,9,15 Whole blood (DNA) דם מלא(DNA) SNP

Detection by TaqMan with

specific fluorescent probes

RT PCR ABI 7500

Applied Biosystem ---

HPA- human Platelet antigen

Page 23: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 23 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Coagulation המטולוגיה, קרישה -בריאות, רפואה שפחת מוצרים: מ

Biological Testing, Platelet function תפקודי טסיות, בדיקות ביולוגיות

123 A P Platelet aggregation

for bleeding evaluation

Plasma, (Na Citrate) פלסמהNa Citrate)) Aggregation induced by ADP,

Epinephrin, Collagen ,

Ristocetin from Helena, Diamed, Molab

Aggram aggregometer

Helena ---

124 A P Platelet aggregation

for monitoring anti

platelet drugs

Plasma, (Na Citrate) פלסמהNa Citrate)) Aggregation induced by ADP,

Epinephrin, Arachidonic acil,

from Diamed and Molab

Aggram aggregometer

Helena ---

Page 24: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 24 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

Endocrinology Laboratory

Tel Hashomer 52621 Israel

Organization name

Laboratory name

Address

+972-3-530-2022, +972-3-530-3082 Phone

+972-3-530-2083 Fax

[email protected]

[email protected]

E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

Opinion and Interpretation

Remarks

Group of products: Health, Medicine - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים

Biological Testing, Immunoassays by Autoanalysers ,אימונוכימיות באוטואנלייזרים שיטותבדיקות ביולוגיות

125 A P -hCG (- human Chorionic Gonadotropin)

-hCG (- human Chorionic Gonadotropin)

Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

126 A P 17-Estradiol 17-Estradiol Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

127 A P 25-OH-Vitamin D 25-OH-Vitamin D Serum סרום Immunoassay/

Chemiluminescence LIAISON

---

128 A P ACTH ACTH Plasma סרום Immunoassay/

Chemiluminescence Immulite 2000

---

129 A P Cortisol Cortisol Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

Page 25: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 25 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים

Biological Testing, Immunoassays by Autoanalysers ,ימיות באוטואנלייזריםאימונוכ שיטותבדיקות ביולוגיות

130 A P C-peptide C-peptide Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

131 A P DHEA-S

(DehydroepiandrosteroneSulfate)

DHEA-S

(DehydroepiandrosteroneSulfate)

Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

132 A P FSH (Follicular

Stimulating Hormone)

FSH (Follicular

Stimulating Hormone)

Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

133 A P GH (Growth

Hormone) GH (Growth Hormone) Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

134 A P IGF-1 (Insulin-like

Growth Factor 1) IGF-1 (Insulin-like

Growth Factor 1) Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

135 A P Insulin אינסולין Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

136 A P LH (Luteinizing

Hormone)

LH (Luteinizing

Hormone)

Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

137 A P PRL (Prolactin) PRL (Prolactin) Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

138 A P Progesterone פרוגסטרון Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

139 A P PTH-I (Para Thyroid

Hormone-Intact)

PTH-I (Para Thyroid

Hormone-Intact)

Plasma

/Immunoassay פלסמה

Chemiluminescence Immulite 2000

---

140 A P Testosterone טסטוסטרון Serum

/Immunoassay סרום

Chemiluminescence Immulite 2000

---

Page 26: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 26 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים

Biological Testing, Immunoassays by Autoanalysers ,אימונוכימיות באוטואנלייזרים שיטותבדיקות ביולוגיות

141 A P Thyroglobulin Thyroglobulin Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

142 A P Thyroglobulin Ab Thyroglobulin Ab Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

143 A P TPO Ab (Thyroid

Peroxidase-Ab) TPO Ab (Thyroid

Peroxidase-Ab) Serum סרום Immunoassay/

Chemiluminescence Immulite 2000

---

Page 27: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 27 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים

Biological Testing, Manual Immunoassays ידניות אימונוכימיות שיטות , בדיקות ביולוגיות

144 A P Aldosterone Aldosterone Serum סרום RIA DPC Kit ---

RIA= Radioimmunoassay

145 A P Androstenedione Androstenedione Serum סרום RIA DSL Kit ---

146 A P Cortisol (Free) )קורטיזול )חופשי Urine 24 HR שעות 42איסוף שתן RIA DPC Kit ---

147 A P GAD Ab (Glutamic

Acid Decarboxylase

Ab)

GAD Ab (Glutamic

Acid Decarboxylase Ab)

Serum סרום IRMA CIS Kit ---

IRMA= Immunoradiometric

Assay

148 A P Progesterone 17-OH

(Progesterone 17-Hydroxy)

Progesterone 17-OH

(Progesterone 17-Hydroxy)

Serum סרום RIA CIS Kit ---

149 A P Renin Activity Renin Activity Plasma פלסמה RIA CIS Kit ---

Page 28: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 28 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Endocrinology :אנדוקרינולוגיה -בריאות, רפואה משפחת מוצרים

Chemical Testing, Chromatography ,כרומטוגרפיה בדיקות כימיות

150 A P Glycated HbAlC Glycated HbAlC Whole blood דם מלא HPLC D-10 ---

HPLC=High Pressure Liquid

Chromatography

Automatic System

Page 29: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 29 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

Gastroenterology Laboratory

Tel Hashomer 52621

Israel

Organization name

Laboratory name

Address

+972-3-530-2905 Phone +972-3-530-2913 Fax [email protected] E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

Opinion and Interpretation

Remarks

Group of products: Health, Medicine - Microbiology, Viruses :מיקרוביולוגיה, נגיפים -בריאות, רפואה משפחת מוצרים

Biological Testing, Non Culture Identification Ttyping - Immunoassays in

Autoanalysers

באוטואנלייזרים אימונוכימיות שיטות – תרבית ללא ואפיון זיהוי, בדיקות ביולוגיות

151 A P Virus: Hepatitis A Ab

(IgM)

Virus: Hepatitis A Ab

(IgM)

Serum סרום MEIA AxSYM Abbott Kit ---

MEIA= Microparticle Enzyme

Immuno Assay

152 A P Virus: Hepatitis B

Core Ab (Total)

Virus: Hepatitis B Core

Ab (Total)

Serum סרום MEIA AxSYM Abbott Kit ---

153 A P Virus: Hepatitis B e.

Ab

Virus: Hepatitis B e. Ab Serum סרום MEIA AxSYM Abbott Kit ---

154 A P Virus: Hepatitis B e.

Ag

Virus: Hepatitis B e. Ag Serum סרום MEIA AxSYM Abbott Kit ---

155 A P Virus: Hepatitis. B

Core Ab (IgM)

Virus: Hepatitis. B Core

Ab (IgM)

Serum

MEIA AxSYM Abbott Kit סרום---

Page 30: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 30 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Microbiology, Viruses :מיקרוביולוגיה, נגיפים -בריאות, רפואה משפחת מוצרים

Biological Testing, Non Culture Identification Ttyping - Immunoassays in

Autoanalysers

באוטואנלייזרים אימונוכימיות שיטות – תרבית ללא ואפיון זיהוי, בדיקות ביולוגיות

156 A P Virus: Hepatitis.A Ab

(Total)

Virus: Hepatitis.A Ab

(Total)

Serum סרום MEIA AxSYM Abbott Kit ---

157 A P Virus: Hepatitis.B

Surface Ab

Virus: Hepatitis.B

Surface Ab

Serum סרום MEIA AxSYM Abbott Kit ---

Page 31: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 31 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

Hematology Laboratory

Tel Hashomer 52621, Israel

Organization name

Laboratory name

Address +972-3-530-2356 Phone +972-3-530-3506 Fax [email protected] E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

Opinion and Interpretation

Remarks

Group of products: Health, Medicine - Hematology :המטולוגיה -בריאות, רפואה משפחת מוצרים

Biological Testing, Cell Typing by FACS Analysis ,ב תאים איפיון בדיקות ביולוגיות- FACS

158 A P Cell Markers

Diagnosis and follow

up of: AML, ALL, CLL,

Lymphomas, NB,

PNH, MDS MRD of ALL and

CLL.

Quantization of stem cells in transplants

from peripheral blood

stem cell collections, B.M, cord blood.

Identify lymphocyte

subpopulations in peripheral blood.

DNA content and Cell

Cycle.

Cell Markers

Diagnosis and follow up

of: AML, ALL, CLL,

Lymphomas, NB, PNH,

MDS MRD of ALL and CLL.

Quantization of stem

cells in transplants from peripheral blood stem

cell collections, B.M,

cord blood. Identify lymphocyte

subpopulations in

peripheral blood. DNA content and Cell

Cycle.

Bone marrow, peripheral

blood, body fluids

מח עצם, דם היקפי , נוזלי גוף

Immunofluorescence by Flow

Cytometry

On whole blood or

Ficol separated cells.

Using monoclonal and

polyclonal Antibodies.

Reagents of: Beckman Coulter,

Becton Dickinson, Dako, e-

Bioscience, IQP, Invitrogen,

Biolegend

Canto II

---

FACS = Fluorescence

Activated Cell Sorter

AML, ALL= Acute leukemias

CLL= Chronic leukemias NB = Neuroblastoma

PNH = Paroxysmal nocturnal

hemoglobinuria

MDS = Myelodysplastic

syndromes

MRD = Minimal residual disease

Page 32: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 32 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology :המטולוגיה -בריאות, רפואה משפחת מוצרים

Biological Testing, Cell Typing by FACS Analysis ,ב תאים איפיון בדיקות ביולוגיות- FACS

159 A P Cell Markers

See the test above Cell Markers

See the test above

Bone marrow, peripheral

blood, body fluids

מח עצם, דם היקפי , נוזלי גוף

Immunofluorescence by Flow

Cytometry

On whole bone marrow or

Ficol separated cells.

Using monoclonal and

polyclonal Antibodies.

Reagents of: Beckman

Coulter, Becton Dickinson,

Dako, e-Bioscience, IQP, Invitrogen, Biolegend

Becton Dickinson

FACSCalibur

---

Page 33: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 33 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology :המטולוגיה -בריאות, רפואה משפחת מוצרים

Biological Testing, Blood Cell Typing Manual smear ידני משטח ,בדיקות ביולוגיות, אפיון תאי דם

160 A P Blood Smears or

Films:

Normal blood films

Young cells: Stabs, MetaMyelocytes,

Myelocytes,

Promyrlocytes, Blasts.

Atypical

Lymphocytes.,

Monocytes, Granulocytes

Red Blood Cell

pathology. Leukemic blood

smears.

Abnormalities in Platelets.

Blood Smears or Films:

Normal blood films

Young cells: Stabs,

MetaMyelocytes, Myelocytes,

Promyrlocytes, Blasts.

Atypical Lymphocytes.,

Monocytes,

Granulocytes

Red Blood Cell pathology.

Leukemic blood smears.

Abnormalities in Platelets.

Whole blood דם מלא Microscopy on Gimsa stained

slides.

Manual and

automatically spread

blood smears by Beckman Coulter 755.

---

Page 34: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 34 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Hematologic Cytogenetics :המטולוגיה, ציטוגנטיקה המטולוגית -בריאות, רפואה משפחת מוצרים

Biological Testing, Cariotyping/Chromosome Analysis נג/בדיקת כרומוזומים קאריוטייפי, בדיקות ביולוגיות

161 A P Karyotype analysis of

Hematological

diseases and malignancies: AML,

CML, ALL, MDS,

Lymphomas. Other malignancies:

NB, PNET

Karyotype analysis of

Hematological diseases

and malignancies: AML, CML, ALL, MDS,

Lymphomas.

Other malignancies: NB, PNET

Bone marrow, peripheral

blood

Light microscopy on G banded מח עצם, דם היקפי

chromosomes

Microscope (Nikon) and

computerized image

acquisition and analysis system for karyotyping

(ASI) ---

AML, ALL= Acute leukemias

CLL, CML= Chronic

leukemias MDS = Myelodysplastic

syndromes NB = Neuroblastoma PNET = Primitive

neuroectodermal tumors

Page 35: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 35 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Hematologic Cytogenetics :המטולוגיה, ציטוגנטיקה המטולוגית -בריאות, רפואה משפחת מוצרים

Biological Testing, FISH FISH , בדיקות ביולוגיות

162 A P Molecular cytogenetic Diagnosis and follow-up

of Neuroblastoma, N-

MYC amplification, -

MLL.

Molecular cytogenetic Diagnosis and follow-up of

Neuroblastoma, N-MYC

amplification, -MLL.

Bone marrow, and solid

tumors

FISH Fluorescent microscope מח עצם, גידולים מוצקים

---

FISH = Fluorescent In Situ

Hybridization

163 A P Molecular cytogenetic Diagnosis and follow-up

of

Ewing Sarcoma:

t(11;22).

Molecular cytogenetic Diagnosis and follow-up of

Ewing Sarcoma: t(11;22).

Bone marrow, and solid

tumors

FISH Fluorescent microscope מח עצם, גידולים מוצקים

---

164 A P Molecular cytogenetic Diagnosis and follow-up

of

CML: bcr/abl , bcr/ablES,

bcr/abl-dual fusion.

CML blast crisis:

bcr/abllES, +8.

Molecular cytogenetic Diagnosis and follow-up of

CML: bcr/abl , bcr/ablES,

bcr/abl-dual fusion.

CML blast crisis:

bcr/abllES, +8.

Bone marrow, peripheral

blood

FISH Fluorescent microscope מח עצם, דם היקפי

---

165 A P Molecular cytogenetic Diagnosis and follow-up

of AML: t(8;21), inv(16),

+8, MLL rearrangements,

t(15;17), -5/5q31-, -

7/7q31-, +8, 20q-.

Molecular cytogenetic Diagnosis and follow-up of

AML: t(8;21), inv(16), +8,

MLL rearrangements,

t(15;17), -5/5q31-, -7/7q31-,

+8, 20q-.

Bone marrow, peripheral

blood

FISH Fluorescent microscope מח עצם, דם היקפי

---

166 A P Molecular cytogenetic Diagnosis and follow-up

of CLL: +12, - p53,

13q14-, 11q-, 6q-.

Molecular cytogenetic Diagnosis and follow-up of

CLL: +12, - p53, 13q14-,

11q-, 6q-.

Bone marrow, peripheral

blood

FISH Fluorescent microscope מח עצם, דם היקפי

---

Page 36: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 36 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Hematologic

Cytogenetics

המטולוגיה, ציטוגנטיקה המטולוגית -בריאות, רפואה משפחת מוצרים:

Biological Testing, FISH ,בדיקות ביולוגיות FISH

167 A P Molecular cytogenetic Diagnosis and follow-up

of ALL: bcr/ablES, +4,+

6,+10, +17,+21),

t(12;21),12p-, 9p21-,

MLL rearrangements.

Molecular cytogenetic Diagnosis and follow-up of

ALL: bcr/ablES, +4,+

6,+10, +17,+21),

t(12;21),12p-, 9p21-, MLL

rearrangements.

Bone marrow, peripheral

blood

FISH Fluorescent microscope מח עצם, דם היקפי

---

168 A P Molecular cytogenetic Diagnosis and follow-up

of Anaplastic Large T-

Cell Lymphoma: t(2;5).

Follicular Lymphoma:

t(14;18), IGH

rearrangements.

Mantle Cell Lymphoma:

t(11;14), 13q14.3-, IGH

rearrangements.

Burkitt's Lymphoma:

t(8;14), C-MYC

rearrangements.

Diffuse Large B-cell

Lymphoma: BCL6(3q27)

rearrangements.

MALT Lymphoma:

MALT1 (18q21)

rearrangements.

Molecular cytogenetic Diagnosis and follow-up of

Anaplastic Large T-Cell

Lymphoma: t(2;5).

Follicular Lymphoma:

t(14;18), IGH

rearrangements.

Mantle Cell Lymphoma:

t(11;14), 13q14.3-, IGH

rearrangements.

Burkitt's Lymphoma:

t(8;14), C-MYC

rearrangements.

Diffuse Large B-cell

Lymphoma: BCL6(3q27)

rearrangements.

MALT Lymphoma:

MALT1 (18q21)

rearrangements.

Bone marrow, peripheral

blood

FISH Fluorescent microscope מח עצם, דם היקפי

---

169 A P Molecular cytogenetic Diagnosis and follow-up

of

Post-Allogeneic BMT:

XX/XY

Molecular cytogenetic Diagnosis and follow-up of

Post-Allogeneic BMT:

XX/XY

Bone marrow, peripheral

blood

FISH Fluorescent microscope מח עצם, דם היקפי

---

Page 37: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 37 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Hematology, Hematologic

Cytogenetics

המטולוגיה, ציטוגנטיקה המטולוגית -בריאות, רפואה משפחת מוצרים:

Biological Testing, FISH ,בדיקות ביולוגיות FISH

170 A P Molecular cytogenetic Diagnosis and follow-up

of MDS: -5/5q31-, -

7/7q31-, +8, 20q-.

Molecular cytogenetic Diagnosis and follow-up of

MDS: -5/5q31-, -7/7q31-,

+8, 20q-.

Bone marrow, peripheral

blood

FISH Fluorescent microscope מח עצם, דם היקפי

---

Page 38: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 38 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

Lipids and Atherosclerosis Laboratory

Tel Hashomer 52621

Israel

Organization name

Laboratory name

Address

+972-3-530-2940 Phone +972-3-530-4431 Fax [email protected] E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

Chemical Testing, Autoanalysers ,באוטואנלייזרים שיטותבדיקות כימיות

171 A P Apolipoprotein A1 Apolipoprotein A1 Plasma, Serum פלסמה, סרום Immunoturbido-metric Olympus AU400 / kit

by Beckman Coulter ---

172 A P Apolipoprotein B Apolipoprotein B Plasma, Serum פלסמה, סרום Immunoturbido-metric Olympus AU400 / kit

by Beckman Coulter ---

173 A P Apolipoprotein CII Apolipoprotein CII Plasma, Serum פלסמה, סרום Immunoturbido-metric Olympus AU400 / kit

by Kamiya ---

174 A P Apolipoprotein CIII Apolipoprotein CIII Serum סרום Immunoturbido-metric Olympus AU400 / kit

by Kamiya ---

175 A P Cholesterol כולסטרול Plasma, Serum

Enzymantic /Colorimetric Olympus AU400 / kit פלסמה, סרום

by Beckman Coulter ---

Page 39: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 39 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, General Biochemistry :כימיה, ביוכימיה כללית -בריאות, רפואה משפחת מוצרים

Chemical Testing, Autoanalysers ,באוטואנלייזרים שיטותבדיקות כימיות

176 A P HDL (High Density

Lipoprotein) cholesterol

HDL (High Density

Lipoprotein) cholesterol

Plasma, Serum פלסמה, סרום Enzymantic /Colorimetric Olympus AU400 / kit

by Beckman Coulter ---

177 A P High sensitive C–

reactive protein

High sensitive C–

reactive protein

Plasma, Serum פלסמה, סרום Immunoturbido-metric Olympus AU400 / kit

by Beckman Coulter ---

178 A P LDL (Low Density

Lipoprotein) cholesterol

LDL (Low Density

Lipoprotein) cholesterol

Plasma, Serum פלסמה, סרום Enzymantic /Colorimetric Olympus AU400 / kit

by Beckman Coulter ---

179 A P Lipoprotein (a) Lipoprotein (a) Plasma, Serum פלסמה, סרום Immunoturbido-metric Olympus AU400 / kit

by Kamiya ---

180 A P Triglycerides Triglycerides Plasma, Serum פלסמה, סרום Enzymantic /Colorimetric Olympus AU400 / kit

by Beckman Coulter ---

Page 40: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 40 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Name and Address:

Sheba Medical Center

Clinical Toxicology & Pharmacology

Tel Hashomer 52621

Israel

Organization name

Laboratory name

Address

+972-3-530-2358 Phone +972-3-535-1596 Fax [email protected] E-Mail

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used / Work station

Opinion and Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, Toxicology and

Pharmacology

כימיה, טוקסיקולוגיה ופרמקולוגיה -בריאות, רפואה משפחת מוצרים:

Chemical Testing, Autoanalysers באוטואנלייזרים שיטות, בדיקות כימיות

181 A P Acetyl Choline

Esterase

Acetyl Choline Esterase RBC אדומים תאי דם Elman-Colorimetric Olympus 640AU

2700AU kit by Microgenics.

--- RBC=Red Blood Cell

182 A P Amphetamines אמפטמינים Urine שתן EMIT Olympus AU640

2700AU

kit by Microgenics

---

EMIT=Enzyme Mediated

Immunoassay Technique

183 A P Barbiturates ברביטורטים Urine שתן EMIT Olympus AU640

2700AU kit by Microgenic

---

184 A P Benzodiazepines Benzodiazepines Urine שתן EMIT Olympus AU640

2700AU

kit by Microgenic ---

Page 41: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 41 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, Toxicology and

Pharmacology

כימיה, טוקסיקולוגיה ופרמקולוגיה -בריאות, רפואה משפחת מוצרים:

Chemical Testing, Autoanalysers ,באוטואנלייזרים שיטותבדיקות כימיות

185 A P Cannabinoids Cannabinoids Urine שתן EMIT Olympus AU640

2700AU

kit by Microgenic ---

186 A P Cocaine metabolite Cocaine metabolite Urine שתן

EMIT Olympus AU640

2700AU

kit by Microgenic

---

187 A P Creatinine Creatinine Urine שתן Colorimetric Olympus 640AU

2700AU

kit by Olympus

DRI Microgenics.

---

188 A P EDDP (2-Ethylidene

1.5-Dimethyl 3.3-

Diphenylpyrrolidine)

EDDP (2-Ethylidene

1.5-Dimethyl 3.3-Diphenylpyrrolidine)

Urine שתן EMIT Olympus AU640

2700AU kit by Microgenic

---

Methadone metabolite

189 A P Methadone מתאדון Urine שתן EMIT Olympus AU640

2700AU

kit by Microgenic

---

190 A P Opiates אופיאטים Urine שתן EMIT Olympus AU640

2700AU

kit by Microgenic ---

191 A P Pseudo Choline

Esterase

Pseudo Choline Esterase Serum/Plasma סרום / פלסמה Elman-Colorimetric Olympus 640AU

2700AU ---

192 A P Tri-Chloro-Acetic acid Tri-Chloro-Acetic acid Urine שתן Colorimetric Spectrophotometer ---

Page 42: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 42 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, Toxicology and

Pharmacology

כימיה, טוקסיקולוגיה ופרמקולוגיה -בריאות, רפואה משפחת מוצרים:

Chemical Testing, Autoanalysers ,באוטואנלייזרים שיטותבדיקות כימיות

193 A P ZPP (Zinc Proto

Porphyrin)

ZPP (Zinc Proto

Porphyrin)

Whole blood דם מלא hematofluorimeter Proto Fluor-Z

(Hematofluorimeter -

Helena laboratries)

---

Page 43: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 43 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, Toxicology and

Pharmacology

כימיה, טוקסיקולוגיה ופרמקולוגיה -בריאות, רפואה משפחת מוצרים:

Chemical Testing, Chromatography גרפיה כרומטו, כימיות בדיקות

194 A P Alcohol אלכוהול Blood דם Chromatography GC-HS/FID

(HP 7890A) ---

HS: Head Space

FID: Flame Ionization

Detector

195 A P Alcohol אלכוהול Urine שתן GC-HS/FID GC-HS/FID

(HP 7890A) ---

196 A P Amphetamines יםאמפטמינ Urine שתן Chromatography GC/MS

(HP 6090 & HP 8970) ---

GC/MS=Gas

Chromatography/Mass

Spectroscopy

197 A P Cannabinoids קנבינואידים Urine שתן Chromatography GC/MS

(HP 6090 & HP 8970) ---

198 A P Cocaine קוקאין Urine שתן Chromatography GC/MS

(HP 6090 & HP 8970) ---

199 A P Hippuric & M-

Hippuric acid

Hippuric & M-Hippuric

acid

Urine שתן Chromatography HPLC

(HP 1100) ---

HPLC=High Pressure Liquid

Chromatography

200 A P Mandelic acid & PGA

(Phenyl Glyoxylic Acid)

Mandelic acid & PGA

(Phenyl Glyoxylic Acid)

Urine שתן Chromatography HPLC

(HP 1100) ---

201 A P Opiates אופיאטים Blood דם Chromatography LC/MS (Micromass

Quattro Ultima Pt) ---

202 A P Opiates יםאופיאט Urine שתן Chromatography GC/MS

(HP 6090 & HP 8970) ---

Page 44: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 44 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, Toxicology and

Pharmacology

כימיה, טוקסיקולוגיה ופרמקולוגיה -בריאות, רפואה משפחת מוצרים:

Chemical Testing, Chromatography כרומטוגרפיה יקות כימיות, בד

203 A P Phenol פנול Urine

Chromatography HPLC שתן

(HP 1100) ---

204 A P tt(trans, trans)-

Muconic acid

tt(trans, trans)-Muconic

acid

Urine שתן Chromatography HPLC

(HP 1100) ---

Page 45: Department Testing Laboratory Medical ISO 15189

115

Accreditation No.

ISO 15189

Testing Laboratory-Medical

Department:

115-04 Appendix to Certificate No.

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 45 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Types of Test / Properties Measured Materials / Samples Tested Test principle / Characteristics Equipment used /

Work station

Opinion and

Interpretation

Remarks

Group of products: Health, Medicine - Chemistry, Toxicology and

Pharmacology

כימיה, טוקסיקולוגיה ופרמקולוגיה -בריאות, רפואה משפחת מוצרים:

Chemical Testing,, Spectroscopy ספקטרוסקופיה, כימיות בדיקות

205 A P Arsenic ארסן Urine שתן Spectroscopy AAS

Perkin-Elmer

Analyst800

---

AAS-Atomic Absorption

Spectroscopy

206 A P Cadmium קדמיום Urine שתן Spectroscopy AAS

Perkin-Elmer

Analyst800

---

207 A P Cadmium קדמיום Whole blood דם מלא Spectroscopy AAS

Perkin-Elmer

Analyst800

---

208 A P Chrome כרום Urine שתן Spectroscopy AAS

Perkin-Elmer Analyst800 & Varian

AA280Z

---

209 A P Cobalt קובלט Urine שתן Spectroscopy AAS

Perkin-Elmer Analyst800

---

210 A P Lead עופרת Urine שתן Spectroscopy AAS

Perkin-Elmer

Analyst800

---

211 A P Lead עופרת Whole blood דם מלא Spectroscopy AAS

Perkin-Elmer Analyst800

---

212 A P Nickel ניקל Urine שתן Spectroscopy AAS

Perkin-Elmer

Analyst800

---

Page 46: Department Testing Laboratory Medical ISO 15189

115 Accreditation No. ISO/IEC 17025 Testing Laboratory Department:

115-04 Appendix to Certificate No.

Schedule of Accreditation

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 46 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח התעודה המצ

Item Scope

Type

Site Materials / Products Tested Types of Test / Properties Measured Standard / Method Opinion and

Interpretation

Remarks

Group of products: Forensic Exhibits מוצגים פורנסיים: משפחת מוצרים

Chemical Testing, Classical chemistry ימיה קלאסיתבדיקות כימיות, כ

213 A P Forensic exhibits מוצגים פורנסיים Cannabis חשיש/ מריחואנה Color ---

Color test , Duquenois Levine

Page 47: Department Testing Laboratory Medical ISO 15189

115 Accreditation No. ISO/IEC 17025 Testing Laboratory Department:

115-04 Appendix to Certificate No.

Schedule of Accreditation

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 47 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Materials / Products Tested Types of Test / Properties Measured Standard / Method Opinion and

Interpretation

Remarks

Group of products: Forensic Exhibits מוצגים פורנסיים: משפחת מוצרים

Chemical Testing, Chromatography בדיקות כימיות,כרומטוגרפיה

214 A P Forensic exhibits מוצגים פורנסיים Amphetamines אמפטמינים

Chromatography --- HP 6090 & HP 8970 & Finnigen Polaris Q

215 A P Forensic exhibits מוצגים פורנסיים Cannabis Chromatography --- TLC=Thin Layer Chromatography חשיש/ מריחואנה

216 A P Forensic exhibits מוצגים פורנסיים Cannabis חשיש/ מריחואנה

Thin-layer

Chromatography --- HP 6090 & HP 8970 & Finnigen Polaris Q

217 A P Forensic exhibits מוצגים פורנסיים General drugs screening Chromatography --- HP 6090 & HP 8970 & Finnigen Polaris Q סריקת סמים כללית

218 A P Forensic exhibits מוצגים פורנסיים LSD (Lysergic acid

Diethylamide) LSD Chromatography --- HP 6090 & HP 8970 & Finnigen Polaris Q

Page 48: Department Testing Laboratory Medical ISO 15189

115 Accreditation No. ISO/IEC 17025 Testing Laboratory Department:

115-04 Appendix to Certificate No.

Schedule of Accreditation

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 48 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Materials / Products Tested Types of Test / Properties Measured Standard / Method Opinion and

Interpretation

Remarks

Group of products: Environment - Air :אויר -איכות סביבה משפחת מוצרים

Chemical Testing, Chromatography, GC ,בדיקות כימיות, כרומטוגרפיה GC

219 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Alcohols combined כוהלים משולבים In house procedure --- Based on: NIOSH 1405

GC/FID (HP 7890A & HP 5890) Compounds:

n-butyl alcohol, sec- butyl alcohol,

isobutyl alcohol, n-propyl alcohol

220 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Alcohols I כוהליםI In house procedure --- NIOSH= The National Institute for Occupational Safety and Health

Based on: NIOSH 1400 GC/FID (HP 7890A & HP 5890)

Compounds: Ethanol, Isopropyl alcohol

221 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Alcohols IV כוהליםIV In house procedure --- Based on: NIOSH 1403 GC/FID

(HP 7890A & HP 5890)

Compounds:

2-butoxyethanol, 2-ethoxyethanol, 2-methoxyethanol,

222 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Epichlorohydrine אפיכלורוהידרין In house procedure --- Based on: NIOSH 1010

GC/FID (HP 7890A & HP 5890)

223 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Esters I

I In house procedure --- Based on: NIOSH 1450אסטרים

GC/FID (HP 7890A & HP 5890)

Compounds: Butyl acetate

Page 49: Department Testing Laboratory Medical ISO 15189

115 Accreditation No. ISO/IEC 17025 Testing Laboratory Department:

115-04 Appendix to Certificate No.

Schedule of Accreditation

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 49 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Materials / Products Tested Types of Test / Properties Measured Standard / Method Opinion and

Interpretation

Remarks

Group of products: Environment - Air :וירא -איכות סביבה משפחת מוצרים

Chemical Testing, Chromatography, GC ,בדיקות כימיות, כרומטוגרפיהGC

224 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Hydrocarbons 36-126 °C BP 36-126פחממנים °C BP In house procedure --- BP = Boiling Point

Based on: NIOSH 1500 GC/FID (HP 7890A & HP 5890)

Compounds: Hexane

225 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Hydrocarbons, ,Halogenated הלוגניםפחמימנים In house procedure --- Based on: NIOSH1003

GC/FID (HP 7890A & HP 5890) Compounds:

Chloroform,tetrachloroethylene ,1,1,1-trichloroethane

Carbon tetrachloride

226 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Hydrocarbons, Aromatic פחמימנים ארומטיים In house procedure --- Based on: NIOSH 1501 GC/FID (HP 7890A & HP 5890)

Compounds: Benzene, Styrene, Toluene,

Xylene

227 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Ketones I קטוניםI In house procedure --- Based on: NIOSH 1300

GC/FID (HP 7890A & HP 5890)

Compounds:

MIBK(methyl isobutyl ketone

228 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Methyl acrylate מתיל אקרילאט In house procedure --- Based on: NIOSH 1459

GC/FID (HP 7890A & HP 5890)

229 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Methyl ethyl ketone

(2-butanone)

In house procedure --- Based on: NIOSH 2500 מתיל אתיל קטון

GC/FID (HP 7890A & HP 5890)

Page 50: Department Testing Laboratory Medical ISO 15189

115 Accreditation No. ISO/IEC 17025 Testing Laboratory Department:

115-04 Appendix to Certificate No.

Schedule of Accreditation

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 50 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Materials / Products Tested Types of Test / Properties Measured Standard / Method Opinion and

Interpretation

Remarks

Group of products: Environment - Air :אויר -ביבה איכות סמשפחת מוצרים

Chemical Testing, Chromatography, GC ,בדיקות כימיות, כרומטוגרפיהGC

230 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Methyl methacrylate מתיל מתאקרילאט In house procedure --- Based on: NIOSH 2537

GC/FID (HP 7890A & HP 5890)

231 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Methylene chloride מתילן כלוריד In house procedure --- Based on: NIOSH 1005

GC/FID (HP 7890A & HP 5890)

232 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Trichloroethylene טריכלורואתילן In house procedure --- Based on: NIOSH 1022 GC/FID (HP 7890A & HP 5890)

233 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Vinyl chloride רידוויניל כל In house procedure --- Based on: NIOSH 1007

GC/FID (HP 7890A & HP 5890)

Page 51: Department Testing Laboratory Medical ISO 15189

115 Accreditation No. ISO/IEC 17025 Testing Laboratory Department:

115-04 Appendix to Certificate No.

Schedule of Accreditation

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 51 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Materials / Products Tested Types of Test / Properties Measured Standard / Method Opinion and

Interpretation

Remarks

Group of products: Environment - Air אויר -איכות סביבה משפחת מוצרים:

Chemical Testing, Spectroscopy, UV/Visible תחום נראה/ספקטרוסקופיה, בדיקות כימיות ,UV

234 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Aromatic isocyanates איזוציאנטים ארומטים In house procedure ---

Page 52: Department Testing Laboratory Medical ISO 15189

115 Accreditation No. ISO/IEC 17025 Testing Laboratory Department:

115-04 Appendix to Certificate No.

Schedule of Accreditation

Site: P or T or M, P-Permanent, T-Temporary, M-Mobile Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's

approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.

Date of issue 26.08.2013 Version No. 4 Page No. 52 of: 52

The certificate attached is an integral part of the schedule and is numbered identicallyהתעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח

Item Scope

Type

Site Materials / Products Tested Types of Test / Properties Measured Standard / Method Opinion and

Interpretation

Remarks

Group of products: Environment - Air :אויר -איכות סביבה משפחת מוצרים

Chemical Testing, Spectroscopy, UV/Visible, Atomic absorption תחום נראה/ספקטרוסקופיה, בדיקות כימיות ,UVבליעה אטומית ,

235 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Arsenic ארסן In house procedure --- Based on: NIOSH P&CAM 173

AAS Varian AA280Z

236 A P Air-Industrial hygiene ינה תעשייתיתהיגי -אויר Beryllium and compounds בריליום ותרכובות In house procedure

--- Based on: NIOSH 7102

AAS Varian AA280Z

237 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Cadmium and compounds קדמיום ותרכובות In house procedure --- Based on: NIOSH 7048

AAS Varian AA280Z & AA280FS

238 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Chromium and compounds כרום ותרכובות In house procedure --- Based on: NIOSH 7024

AAS Varian AA280Z & AA280FS

239 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Cobalt and compounds קובלט ותרכובות In house procedure --- Based on: NIOSH 7027

AAS Varian AA280Z & AA280FS

240 A P Air-Industrial hygiene יינה תעשייתיתהיג -אויר Lead עופרת In house procedure --- Based on: NIOSH 7082

AAS Varian AA280Z& AA280FS

241 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Lead עופרת In house procedure --- Based on: NIOSH 7105

AAS Varian AA280Z

242 A P Air-Industrial hygiene היגיינה תעשייתית -אויר Nickel ניקל In house procedure --- Based on: NIOSH 7105, 7082

AAS Varian AA280Z & AA280FS